Clinical Study of Sorafenib and Zoledronic Acid to Treat... | NCT01259193

Studies
Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

NCT01259193

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Apr 14, 2011Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Hepatocellular Carcinoma

Interventions

Sorafenib and Zoledronic Acid

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
LCI-10-10-20

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Jul 2011Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Dec 13, 2010

First Submission Date that Met QC Criteria

Dec 13, 2010

First Posted Date

Dec 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2011

Last Update Posted Date

Apr 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.

Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer. Emerging data suggest that zoledronic acid may also exhibit anticancer properties.

The objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic Acid and to evaluate overall survival and time to progression.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sorafenib and Zoledronic Acid	Experimental		Drug: Sorafenib and Zoledronic Acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sorafenib and Zoledronic Acid	Drug	Sorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year	Sorafenib and Zoledronic Acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
numbers of adverse events	to evaluate the toxicity of sorafenib in combination with zoledronic acid	1 year

Secondary Outcomes

Measure	Description	Time Frame
Overall survival (OS), time to progression (TTP)	to evaluate the efficacy of sorafenib in combination with zoledronic acid	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
patient with unresectable primary hepatocellular carcinoma
Child-Pugh Class A or B, score ≤ 7
ECOG score 0-2
Expected survival time not less than 12 weeks
At least one tumor nodule with one uni-dimension of ≥ 1 cm
Peripheral platelet of or more than 50×10(9)/L
Peripheral hemoglobin of or more than 85g/L
Peripheral albumen of or more than 28g/L
Total bilirubin ≤3.0mg/dl
ALT and AST ≤ 5.0 x the upper limit of normal
Serum amylase ≤ 1.5x the upper limit of normal
Serum creatinine ≤ 1.5x upper limit of normal
PT-INR<2.3 or PT prolong no more than 4s of normal

Exclusion Criteria:

Congestive heart failure > NYHA class 2
History of active coronary disease( except myocardial infarction more than 6 months ago)
Receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin)
uncontrollable hypertension
Active clinically serious infections (> 2 NCI-CTC Version 3.0)
History of HIV infection
Inclined to hemorrhage or active hemorrhage with 1 month
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
Pregnant or breast-feeding.Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study
Known or suspected allergy to any agent given in association with this trial
Concomitant anti-cancer therapy (except immunotherapy and Chinese traditional treatment)
Surgical operation within 4 weeks prior to enrolling in this portion of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Zheng-Gang Ren, Ph.D	Contact	0086-021-64041990	2149	ren.zhenggang@zs-hospital.sh.cn
Lan Zhang, Master	Contact	0086-021-64041990	2171	zhang.lan@zs-hospital.sh.cn

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals